Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT06230302
Eligibility Criteria:
Inclusion Criteria:
* Adult men and women aged 40 years or older at the time of screening test
* Adult men and women with a Charlson Comorbidity Index (CCI) score of 0 at the time of screening
* Adult men and women with skeletal muscle mass less than 110% of the standard as measured by BIA (bioelectrical impedence analysis) at the time of screening test
Exclusion Criteria:
* Those with significant hypersensitivity to melon gourd, whey, or lactic acid bacteria ingredients
* Those who participated in other human application tests, diet, or exercise programs within 3 months before the screening test
* Persons with clinically significant acute or chronic cardiovascular, diabetes, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, or gastrointestinal diseases requiring treatment.
* Those who show the following results in blood or urine tests: AST, ALT \> 1.5 times the upper limit of the reference range, Serum Creatinine \> 1.4 mg/dL, Fasting blood sugar \> 126mg/dL
* If there is 2+ or more proteinuria
* Persons taking medication for psychiatric illness (excluding cases of intermittent medication due to sleep disorders)
* Those who consumed pro- or prebiotics within 1 month before the screening test
* Those who have taken protein supplements regularly for more than 3 months within 6 months before the screening test
* Those who received other investigational drugs within 1 month before the screening test
* Those who received antibiotics within 2 months before the screening test
* Those who are currently controlling their diet for disease management purposes
* Those with a history of gastrointestinal resection (excluding the appendix)
* Those who are performing or plan to perform regular resistance exercise
* People with vegetarian beliefs
* People with food allergies or restricted foods
* Persons with a history of diagnosed gastrointestinal disease (ex. ulcerative colitis, Crohn's disease, gastroparesis, peptic ulcer disease, cancer, celiac disease, short bowel, and ileostomy)
* Those taking constipation or diarrhea medication
* Those who currently smoke
* Those whose BMI exceeds 30kg/m2 at the time of screening test
* Those who plan to control their weight within 6 months after screening
* Those who are likely to be uncooperative in this test or those who are determined by the researcher to be unable to proceed with the test
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT06230302
Study Brief:
Protocol Section:
NCT06230302